Verathon BladderScan BVI 9400 User manual

BladderScan®BVI 9400
Bladder Volume Instrument
User’s Manual
CAUTION: In the United States, federal law restricts this
device to use by or on the order of a physician.

Copyright © 2008 by Verathon Inc.. All rights reserved. No part of this User’s Manual may be copied or
transmitted by any method without the express written consent of Verathon Inc..
Verathon®, Verathon Medical®, BladderScan®, ScanPoint®, Sontac®, and NeuralHarmonics™ are either
trademarks or registered trademarks, and Total ReliabilitySM Plan is a service mark of Verathon Inc.
Bluetooth®word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by Verathon®
is under license.
Cidex®is a registered trademark of Advanced Sterilization Products.
Sporocidin®is a registered trademark of Aporocidin International.
All other brand and product names are trademarks or registered trademarks of their respective owners.
The BladderScan®technology described in this manual is protected by U.S. Patent Numbers 5,235,985,
6,676,605, and 6,884,217. The ScanPoint®technology described in this manual is protected by U.S. Patent
Number 6,569,097. The Sontac®ultrasound coupling pad described in this manual is protected by U.S. Patent
Number 5,782,767. Other international patents pending.
Information in this User’s Manual may change at any time without notice. For the most up-to-date information,
see the online manuals at http://www.verathon.com. Examples described or illustrated in this User’s Manual
are ctitious and do not in any way represent real patient or exam data.
Corporate Headquarters
20001 North Creek Parkway
Bothell, WA 98011
USA
800.331.2313 (US and Canada only)
425.867.1348
Fax: [phone]
Verathon Medical (Japan) K.K.
Executive Tower Azabudai 7F
1-4-3 Azabudai
Minato-ku, Tokyo 106-0041
Japan
+81.3.3560.3501
Fax: [phone]
Verathon Medical (Europe) B.V.
EC REP
Boerhaaveweg 1
3401 MN IJsselstein
The Netherlands
+31.30.68.70.570
Fax: [phone]
Verathon Medical (France)
BP 10039
F-67012 Strasbourg Cedex
France
+33.3.88.60.14.12
Fax: [phone]
Verathon Medical (United Kingdom) Ltd.
The Granary Manor Farm Courtyard
Aston Sandford, Aylesbury
Buckinghamshire HP17 8JB
United Kingdom
+44.1844.299.207
Fax: [phone]
PN: 0900-1606-01-60

User’s Manual page 5
BladderScan®BVI 9400 Quick Reference - Operation
Turn on the BladderScan®BVI 9400
by pressing the POWER ON/OFF button.
www.verathon.com https://my.scanpoint.com
For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical®representative. BladderScan®, ScanPoint®, Verathon®, and Verathon
Medical®are registered trademarks of Verathon Inc. in the US and other countries. Copyright
© 2008 by Verathon Inc. All rights reserved.
BVI 9400 User’s Quick Reference
On/Off button
Select scanning mode
The BladderScan BVI 9400 is designed to scan in three patient-
specific modes. Select the proper exam mode to ensure the
accuracy of your scan. Simply press the button repeatedly
until the desired setting appears:
Select to scan a male patient, or a female patient who
has had a hysterectomy
Select to scan a female patient who has not had
a hysterectomy
Select to scan a small child under 48 inches (122cm) tall
and weighing less than 60 lbs (27kg)
With the patient supine, apply gel
Have the patient lie in the supine position with abdominal
muscles relaxed.
Palpate the patient's symphysis pubis (pubic bone). Place
an ample quantity of gel (with as few air bubbles as possible)
midline on the patient's abdomen, approximately one inch
(3 cm) above the symphysis pubis.
Aim toward the bladder
Standing at the patient’s right side, place the Probe on the
gel and aim toward the expected location of the bladder.
For most patients, this means tilting the Probe slightly
toward the patient's coccyx (tailbone) so the scan clears
the pubic bone.
Press the SCAN button
Press the SCAN button, located on the underside of the Probe.
As the scan progresses, sections of the bladder will appear on
the console screen. When you hear the end-scan tone, the
scan is complete.
Scan button
Female button
Savings Calculation
Date Started 3/21/2007
Number of Scans 22
CathAvoided 15
UTIAvoided 0
Savings $1500
Savings Calculation
Date Started 3/21/2007
Number of Scans 22
Cath Avoided 15
UTI Avoided 0
Savings $1500

User’s Manual page 6
BladderScan®BVI 9400 Quick Reference - Operation
Verify the scan
If the scan is “on target” all 8 arrows will flash on the Probe
screen, and the bladder will be shown in the center of the
crosshairs on the Console screen. Since no re-aiming is
needed, no arrows will appear on the Console screen.
Finish exam
Once you have completed the scan, wipe the ultrasound gel off the patient and the Probe.
For ScanPoint
®
subscribers, logging on to ScanPoint
®
automatically transfers and saves your annotated exams.
BVI 9400 User’s Quick Reference
Save, review and print exam results
To save the exam, you must annotate it.
To annotate, press and release the RECORD button on the
Console. When you see the RECORD button icon turn to a STOP
button icon, record your patient information by speaking into
the Probe microphone. Press the STOP button on the Console.
When the hourglass icon disappears, press the LISTEN button to
replay the annotation.
To review the images of your scan, press the REVIEW button
(you must first save the exam before you can review it).
To print exam results via on-board printer, press the PRINT
button.
To perform another exam, press the HOME button.
On/Off button
Record Print Listen Review Home
0900-1446-02-60
www.verathon.com https://my.scanpoint.com
For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical
®representative.
Verathon Corporate Headquarters: 20001 North Creek Parkway, Bothell, WA 98011, USA. Phone: [phone]
VM Europe B.V.: Boerhaaveweg 1, 3401 MN IJsselstein, The Netherlands, Phone:[phone]
Re-aiming
If the scan is “off target” the Probe will show an arrow
indicating the direction to move the Probe to be “on target.”
If the arrow is solid, it means you are slightly “off target.”
If the arrow is flashing, it means you are significantly “off
target” and must re-aim and re-scan. On the Console, the
bladder will not be on the crosshairs, and there will be an
arrow pointing in the direction for re-aiming.
To re-aim
To re-aim, note that the small dot at “6 o’clock” on the
Console target represents the feet of the patient. The
“12 o’clock” position represents the head of the patient
and the upper left quadrant (9-12 o’clock) represents the
right shoulder of the patient. This orientation should help
you in re-aiming the Probe to capture the complete bladder
in the ultrasound “cone.”
Pubic Bone
You may also see a screen that indicates the pubic bone is
“inside” the ultrasound cone. If this occurs, you may want
to re-aim and re-scan. Although the bladder may be shown
as centered in the ultrasound cone, and your measurement
could be complete, there is a possibility that the pubic bone
is obscuring some of the bladder. By re-aiming, you can
ensure you have captured the bladder fully inside the
ultrasound cone.
To order additional rolls of paper (0800-0319) or batteries (0400-0066), contact Customer Care at 800.331.2313.
Feet
Head
Right
shoulder
Pubic
bone

User’s Manual page 7
www.verathon.com https://my.scanpoint.com
For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical®representative. ScanPoint®, BladderScan®, Verathon®, and
Verathon Medical®are registered trademarks of Verathon Inc. in the US and other countries. Copyright
© 2007 by Verathon Inc. All rights reserved.
BVI 9400 Calibration Quick Reference
The entire calibration process may take up to 15 minutes. You may calibrate your instrument as often as you like; you do not have
to wait for the next scheduled calibration date. However, at a minimum, you must calibrate the instrument every 12 months.
Prepare for Calibration
Set up the calibration tank in a location that is within
10 feet of Charger and Wireless Hub.
Place the calibration tank on a flat, nonreflective surface and
remove the lid. Pour clean, room temperature water into the
container, filling to the indicator mark. Make sure the water
contains a minimal amount of bubbles. Place the spiral-
shaped target in the container, using the notches to position
target correctly. Replace the lid on the calibration container.
Place the probe
Place the Probe in the cutout in the top of the calibration
tank. Make sure the black tip of the Probe is submerged
in the water.
Open ScanPoint®QuickPrint
From your desktop, open QuickPrint by double-clicking
the QuickPrint icon.
Establish BVI 9400 - QuickPrint
connection
Press the ScanPoint®button on the BVI 9400.
On the QuickPrint screen, click the FIND NEW button.
When QuickPrint establishes a connection with the
BVI 9400, an icon will appear along the left menu.
Savings Calculation
Date Started 3/21/2007
Number of Scans 22
Cath Avoided 15
UTI Avoided 0
Savings $1500
ScanPoint®
button
NOTE: This procedure requires ScanPoint®with QuickPrint Imaging
Technology Software. If your BladderScan®BVI 9400 requires calibration,
and you’re not using ScanPoint®with QuickPrint, please contact Verathon®
Technical Support at 1.800.331.2313 (US & Canada) or 425.867.1348
(International).
BladderScan®BVI 9400 Quick Reference - Operation
Verify the scan
If the scan is “on target” all 8 arrows will flash on the Probe
screen, and the bladder will be shown in the center of the
crosshairs on the Console screen. Since no re-aiming is
needed, no arrows will appear on the Console screen.
Finish exam
Once you have completed the scan, wipe the ultrasound gel off the patient and the Probe.
For ScanPoint
®
subscribers, logging on to ScanPoint
®
automatically transfers and saves your annotated exams.
BVI 9400 User’s Quick Reference
Save, review and print exam results
To save the exam, you must annotate it.
To annotate, press and release the RECORD button on the
Console. When you see the RECORD button icon turn to a STOP
button icon, record your patient information by speaking into
the Probe microphone. Press the STOP button on the Console.
When the hourglass icon disappears, press the LISTEN button to
replay the annotation.
To review the images of your scan, press the REVIEW button
(you must first save the exam before you can review it).
To print exam results via on-board printer, press the PRINT
button.
To perform another exam, press the HOME button.
On/Off button
Record Print Listen Review Home
0900-1446-02-60
www.verathon.com https://my.scanpoint.com
For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical
®representative.
Verathon Corporate Headquarters: 20001 North Creek Parkway, Bothell, WA 98011, USA. Phone: [phone]
VM Europe B.V.: Boerhaaveweg 1, 3401 MN IJsselstein, The Netherlands, Phone:[phone]
Re-aiming
If the scan is “off target” the Probe will show an arrow
indicating the direction to move the Probe to be “on target.”
If the arrow is solid, it means you are slightly “off target.”
If the arrow is flashing, it means you are significantly “off
target” and must re-aim and re-scan. On the Console, the
bladder will not be on the crosshairs, and there will be an
arrow pointing in the direction for re-aiming.
To re-aim
To re-aim, note that the small dot at “6 o’clock” on the
Console target represents the feet of the patient. The
“12 o’clock” position represents the head of the patient
and the upper left quadrant (9-12 o’clock) represents the
right shoulder of the patient. This orientation should help
you in re-aiming the Probe to capture the complete bladder
in the ultrasound “cone.”
Pubic Bone
You may also see a screen that indicates the pubic bone is
“inside” the ultrasound cone. If this occurs, you may want
to re-aim and re-scan. Although the bladder may be shown
as centered in the ultrasound cone, and your measurement
could be complete, there is a possibility that the pubic bone
is obscuring some of the bladder. By re-aiming, you can
ensure you have captured the bladder fully inside the
ultrasound cone.
To order additional rolls of paper (0800-0319) or batteries (0400-0066), contact Customer Care at 800.331.2313.
Feet
Head
Right
shoulder
Pubic
bone

User’s Manual page 8
BladderScan®BVI 9400 Quick Reference - Operation
Successful calibration
If ScanPoint®was able to locate the calibration target,
the instrument analyzes the scan data to ensure that it
meets the calibration parameters. If necessary, the
instrument automatically rescans the phantom. When
calibration is complete, a ‘Calibration Successful’ message
is displayed on your computer.
To print a record of the calibration, click: Click Here for
Printable Certificate of Calibration.
0900-1447-01-60
End calibration
To terminate the calibration procedure and end
communication with the ScanPoint®, press the
CANCEL (X) button on the BVI 9400.
Remove the Probe from the calibration chamber lid and
dry it with a clean, soft cloth.
Failed calibration
If ScanPoint®was unable to locate the calibration target,
it displays an error message and instructs you to ensure
that the calibration chamber has enough water and that
the Probe is seated properly in the calibration system.
You may choose to calibrate again or to quit the
calibration process.
NOTE: If you are unable to calibrate, contact your local
Verathon Medical®representative or Verathon Medical®
Customer Care at 1.800.331.2313.
www.verathon.com https://my.scanpoint.com
For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical®representative.
Verathon Corporate Headquarters: 20001 North Creek Parkway, Bothell, WA 98011, USA. Phone: [phone]
VM Europe B.V.: Boerhaaveweg 1, 3401 MN IJsselstein, The Netherlands, Phone:[phone]
BVI 9400 Calibration Quick Reference
Calibrate instrument
From the Tools menu, select Calibrate Instrument. When
the Calibration screen opens, click the CALIBRATE button.
ScanPoint®then automatically scans and analyzes the
calibration target.
IMPORTANT! Do not remove the Probe from the calibration
chamber until four arrows appear on the Probe’s LCD
screen. Do not disconnect the Charger and Wireless Hub
from the computer or otherwise break the connection
between the BVI 9400 and the ScanPoint®host computer
until all processing is complete.
Calibrate
To order additional rolls of paper (0800-0319) or batteries (0400-0066), contact Customer Care at 800.331.2313.

User’s Manual page 9
Table of Contents
Quick Reference ...................................................................................................................................... 5
President’s Statement............................................................................................................................13
Important Information ............................................................................................................................14
Product Description ..............................................................................................................................14
Intended Use Warnings and Cautions ..................................................................................................14
Biological Safety ...............................................................................................................................14
Statement of Prescription .................................................................................................................15
Statement of Intended Use...............................................................................................................15
Contraindications (U. S. Only) ..........................................................................................................15
Bluetooth®Wireless Technology .......................................................................................................16
Introducing the BladderScan®BVI 9400...............................................................................................17
Product Description ..................................................................................................................................17
BladderScan®Parts and Features........................................................................................................18
Probe Components...........................................................................................................................19
Console Components .......................................................................................................................19
Battery Charger/Wireless Hub..............................................................................................................20
Parts and Accessories ..........................................................................................................................21
Getting Started........................................................................................................................................22
Unpack the Box and Check the Components...........................................................................................22
Charge the Batteries.............................................................................................................................22
Install a Battery Pack in the Console....................................................................................................23
Battery Care .....................................................................................................................................23
Enter the Clinic Name...........................................................................................................................23
Set the Date and Time..........................................................................................................................26
Setting General Preferences and Savings Preferences ...................................................................27
Load a Roll of Thermal Paper...............................................................................................................27
Assemble the Medical Cart...................................................................................................................28
Medical Cart Parts List .....................................................................................................................28
Install the BladderScan®on the Optional Mobile Cart ..........................................................................30
Install the ScanPoint®with QuickPrint Software (Optional) ..................................................................30
Watch the Training Video......................................................................................................................31
BladderScan®BVI 9400 Table of Contents

User’s Manual page 10
Displays, Controls, and Indicators .......................................................................................................31
Console Displays and Button Functions...............................................................................................31
Home Screen....................................................................................................................................31
Scan Screen .....................................................................................................................................33
Results Screen .................................................................................................................................33
Review Screen .................................................................................................................................34
Tutorial Screen .................................................................................................................................35
Video Viewing Screen.......................................................................................................................36
Settings Screen ................................................................................................................................37
Alpha-Numeric Screen .....................................................................................................................38
Date & Time Screen .........................................................................................................................39
General Preferences Screen ............................................................................................................40
Savings Preferences Screen ............................................................................................................41
Self-Test Screen ...............................................................................................................................42
ScanPoint®Screen ...........................................................................................................................43
Sleep Mode ......................................................................................................................................44
Memory Optimization During Power Down.......................................................................................44
Measuring Bladder Volume ...................................................................................................................45
Preparing for the Exam.........................................................................................................................45
Measuring Bladder Volume ..................................................................................................................46
Additional Scanning Tips ......................................................................................................................49
Recording a Voice Annotation ..............................................................................................................49
Deleting a Saved Exam ........................................................................................................................51
Printing .................................................................................................................................................51
Adding Addition Information..............................................................................................................51
Histogram of Cost Savings....................................................................................................................52
Cleaning and Maintenance ....................................................................................................................53
Cleaning and Disinfecting the BladderScan®BVI 9400........................................................................53
Regular Inspections and Maintenance .................................................................................................53
Weekly Inspections...........................................................................................................................54
Using the Built-in Self-Test Utility..........................................................................................................54
Calibrating the BladderScan®BVI 9400 Using the ScanPoint®System ...............................................54
Self-Calibration .................................................................................................................................55
Device Repair .......................................................................................................................................55
BladderScan®BVI 9400 Table of Contents

User’s Manual page 11
Unit Disposal ........................................................................................................................................55
Troubleshooting .....................................................................................................................................56
Help Resources ....................................................................................................................................57
Icons on the BladderScan®Console.....................................................................................................57
Diagnosing problems............................................................................................................................58
Instrument Does Not Turn On...........................................................................................................58
Printer Problems...............................................................................................................................58
No Paper ..........................................................................................................................................58
Too Hot .............................................................................................................................................59
Clearing a Paper Jam.......................................................................................................................59
Warranty ..................................................................................................................................................60
Disclaimer of Additional Warranties ......................................................................................................60
Contacting Verathon®.............................................................................................................................61
Safety and Performance Summary.......................................................................................................62
Parts and Accessories ...........................................................................................................................63
BladderScan®BVI 9400 System Components .....................................................................................63
Product Specications...........................................................................................................................64
Symbol Directory ..................................................................................................................................64
Standards and Regulations Compliance ..............................................................................................64
Electromagnetic Effects....................................................................................................................65
BladderScan® BVI 9400 Instrument Specications ..............................................................................65
Ultrasound Output Parameters.........................................................................................................66
Accuracy Specications....................................................................................................................66
BladderScan®BVI 9400 Operating Conditions.................................................................................67
BladderScan®BVI 9400 Storage Conditions ....................................................................................67
BladderScan®BVI 9400 Displays, Controls, and Indicators .................................................................67
Instrument Buttons ...........................................................................................................................67
Instrument Display............................................................................................................................69
Battery Charger/Wireless Hub Specications.......................................................................................70
Operating Conditions........................................................................................................................71
Storage Conditions ...........................................................................................................................71
Battery Specications ...........................................................................................................................72
Glossary ..................................................................................................................................................73
BladderScan®BVI 9400 Table of Contents

User’s Manual page 12
Table of Figures
Figure 1. BladderScan®BVI 9400 Controls and Indicators .................................................................18
Figure 2. Battery Charger/Wireless Hub..............................................................................................20
Figure 3. Home Screen .......................................................................................................................24
Figure 4. Settings Screen ....................................................................................................................24
Figure 5. Alpha-Numeric Screen .........................................................................................................25
Figure 6. Facility Name in Display Header ..........................................................................................25
Figure 7. Set Up Screen - Date and Time ...........................................................................................26
Figure 8. Date and Time Screen..........................................................................................................26
Figure 9. Medical Cart, PN: 0800-0322 ...............................................................................................28
Figure 10. Medical Cart Assembly.......................................................................................................29
Figure 11. Attaching the BVI 9400 to the Medical Cart........................................................................30
Figure 12. Home Screen .....................................................................................................................32
Figure 13. Scan Screen.......................................................................................................................33
Figure 14. Results Screen ...................................................................................................................33
Figure 15. Review Screen ...................................................................................................................34
Figure 16. Tutorial Screen ...................................................................................................................35
Figure 17. Video Viewing Screen ........................................................................................................36
Figure 18. Settings Screen Start Menu ...............................................................................................37
Figure 19. Alpha-Numeric Screen .......................................................................................................38
Figure 20. Date & Time Screen ...........................................................................................................39
Figure 21. General Preferences Screen..............................................................................................40
Figure 22. Savings Preference Screen................................................................................................42
Figure 23. Self-Test Screen .................................................................................................................42
Figure 24. ScanPoint®Screens ...........................................................................................................43
Figure 25. Sleep Mode Screens ..........................................................................................................44
Figure 26. Memory Optimization Alert .................................................................................................43
Figure 27. Exam Results Printout Using the Onboard Printer .............................................................51
Figure 28. Calibration Warning ............................................................................................................55
Figure 29. Printer Out of Paper Screen ...............................................................................................58

User’s Manual page 13
The team at Verathon®is committed to improving health care delivery by putting
healthcare providers and their patients rst.
Our products support you, the health care provider, by consistently offering accuracy,
utility, reliability and excellence.
Please contact us directly at 1.800.331.2313 (USA and Canada only) or 1.425.867.1348,
if we can improve our service to you.
Sincerely,
Gerald McMorrow
Gerald McMorrow, CEO, Founder and Chairman of the Board
BladderScan®BVI 9400 President’s Statement
President’s Statement

User’s Manual page 14
Product Description
BladderScan®instruments are the gold standard in bladder volume measurement.
The BladderScan®BVI 9400, with patented NeuralHarmonics™ technology, is a portable
ultrasound instrument that provides a noninvasive measurement of urinary bladder volume.
The device consists of an ultrasound probe that scans the patient’s bladder, and a compact,
battery-operated console that provides an array of measurement-related information.
BladderScan®is noninvasive and comfortable for the patient. It is accurate, reliable, quick
and easy to use. When the user releases the scan button, within seconds, BladderScan®
measures ultrasonic reections on multiple planes inside the body and produces a three-
dimensional image. Based on this image, the BladderScan®BVI 9400 calculates and
displays the bladder volume. A sonographer is not required.
Patented NeuralHarmonics™ technology (abbreviated from “neural network harmonics”)
in the BVI 9400, sharpens accuracy and accelerates speed of measurement. Volume
measurements made with NeuralHarmonics™ technology are more accurate than those
from conventional two-dimensional ultrasound, as they are based on a more complex,
multifaceted image of the bladder. This technology, applying multi-spectral analysis to a
robust data set, helps reduce margin of error and minimize uncertainty in essential
measurements of bladder function.
BladderScan®BVI 9400 measurements can be printed via an onboard printer or transmitted,
using HIPAA-compliant ScanPoint®with QuickPrint Imaging Technology Software (optional)
to your ofce or facility computer, for viewing, printing or archiving.
Intended Use Warnings and Cautions
The BladderScan®BVI 9400 should be used only by individuals who have been trained and
authorized by a physician or the institution providing patient care. All users must read this
entire User’s Manual prior to using the BladderScan®BVI 9400. Do not attempt to operate
this instrument until you thoroughly understand all instructions and procedures in this manual.
Failure to comply with these instructions may compromise the performance of the device and
the reliability of its measurements. For the most current version of the User’s Manual, please
visit the Verathon®Web site at: http://www.verathon.com, then select the BladderScan®>
Customer Support links to open a link to this manual and other training materials.
Biological Safety
To date, exposure to pulsed diagnostic ultrasound has not been shown to produce adverse
effects. However, ultrasound should be used only by medical professionals when clinically
indicated, using the lowest possible exposure times indicated by clinical need.
The ultrasound output power of the BladderScan®BVI 9400 is not user adjustable and is
limited to the minimum level necessary for effective performance. Data on acoustic output
levels can be found in the “Technical Description” section of this manual.
Important Information
BladderScan®BVI 9400 Important Information

User’s Manual page 15
Statement of Prescription
United States federal law restricts the BladderScan®BVI 9400 to use by, or on the order of,
a physician. This statement is required per 21 Code of Federal Regulations (CFR) 801.109.
NOTE:
It is standard practice to have medical staff authorize the use of the BladderScan®BVI 9400
within its intended use throughout an institution. Individual prescriptions for use are not required.
Statement of Intended Use
The BladderScan®BVI 9400 projects ultrasound energy through the lower abdomen of
the patient to obtain an image of the bladder which is used to calculate bladder volume
noninvasively.
Contraindications (U. S. Only)
The BladderScan®BVI 9400 is not intended for fetal use or for use on pregnant patients.
To assure safe and reliable operation for the use and the patient, please read and heed the
following warnings and cautions.
WARNING! Risk of explosion.
If you use the BladderScan® BVI 9400 in the presence of ammable anesthetics, the hazard of
potential explosion exists.
WARNING! Risk of explosion, re, or serious injury.
The BladderScan®BVI 9400 is provided with two Lithium Ion batteries. Never short circuit the
battery pack by either accidentally or intentionally bringing the battery terminals into contact with
any other conductive object. This could cause serious injury or re and could also damage the
battery pack and the BladderScan®device.
WARNING! Risk of explosion, re, or serious injury.
Never expose the battery pack to abnormal shock, vibration, or pressure. The main battery
pack’s internal protective covering could fail, causing it to overheat or ignite, resulting in caustic
liquid leakage, or explosion or re, possibly resulting in serious injury.
WARNING! Potential patient hazard.
To date, exposure to low-power, pulsed diagnostic ultrasound has not been shown to produce
adverse effects. However, medical professionals should use ultrasound only when clinically
indicated, using the lowest exposure times possible to obtain accurate measurements. The
ultrasonic output of the BladderScan®BVI 9400 is not user-adjustable and is limited to the
minimum level necessary for effective performance. For more information about the acoustic
output levels of this device, please refer to the section in this manual titled BladderScan®BVI
9400 Instrument Specications on page 65.
BladderScan®BVI 9400 Important Information

User’s Manual page 16
CAUTION: Risk of inaccurate measurements/results.
When using the BladderScan®BVI 9400 be aware of the following conditions which can affect
ultrasound which can affect ultrasound transmission and decrease the accuracy of exam results.
Use care when scanning patients who have had supra-pubic or pelvic surgery. Scar tissue,•
surgical incisions, sutures, and staples can affect ultrasound transmission and accuracy.
Do not use the BladderScan• ®BVI 9400 on a patient with open skin or wounds in the
suprapubic region.
Do not use the BladderScan• ®BVI 9400 on a patient with ascites.
If you scan a patient with a catheter in his/her bladder, the catheter may affect measurement•
accuracy. However, the information obtained from the measurement could still be clinically
useful for detecting problems such as a blocked catheter.
CAUTION: Observe the following precautions in the safe use and care of the
BladderScan®BVI 9400.
Hazardous materials present. Assure proper disposal.
The BladderScan®BVI 9400 and related devices may contain lead, mineral oils, batteries, and
other environmentally hazardous materials. When the BladderScan®BVI 9400 has reached
the end of its useful service life, return the device, charging cradle, and related accessories to a
Verathon®Service Center for proper disposal. Alternatively, follow your local protocols for hazardous
waste disposal.
Assure proper computer system conguration.
When using the BladderScan®BVI 9400 with optional ScanPoint®software, your computer must be
minimally certied to EN / IEC / CSA / UL 60950 or 60101-1 standards. This conguration ensures
that compliance to the EN/IEC 60601-1-1 system standard is maintained. Anyone connecting
additional equipment to the BladderScan® BVI 9400 signal input port or signal output port congures
a medical system, and is therefore responsible for ensuring that the system complies with EN/IEC
60601-1-1. If you need assistance, contact your biomedical staff, Verathon Medical®representative,
or the Verathon Medical®Customer Care Department at 1.800.331.2313.
Assure proper distance from patient.
When transmitting data to or from you computer, make sure that the BladderScan®BVI 9400,
accessories, and computer are outside the patient vicinity (more than six feet (2 meters) from the
patient). Refer to UL 2601-1 Clause 2 deviation for the denition of patient vicinity.
Bluetooth®Wireless Technology
The Bluetooth technology used in the BladderScan®BVI 9400 is compliant with:
Bluetooth Specication as dened and approved by The Bluetooth Special Interests Group.•
Logo certication with Bluetooth wireless technology as dened by The Bluetooth Special •
Interest Group.
CAUTION: Bluetooth and Wireless LAN devices operate within the same radio frequency range and
may interfere with one another. If you are using the BladderScan®BVI 9400 Bluetooth link and Wireless
LAN devices simultaneously, you may experience less than optimal network performance or even loose
your network connection. If this happens, you may need to move the BladderScan®and ScanPoint®
host computer to an area away from the 2.4 GHz wireless LAN devices (40 meters/44 yards, or more).
BladderScan®BVI 9400 Important Information

User’s Manual page 17
Introducing the BladderScan®BVI 9400
Product Description
BladderScan®instruments are the gold standard in bladder volume measurement.
The BladderScan®BVI 9400, with patented NeuralHarmonics™ technology, is a portable
ultrasound instrument that provides a noninvasive measurement of urinary bladder volume.
The device consists of an ultrasound probe that scans the patient’s bladder, and a compact,
battery-operated console that provides an array of measurement-related information.
BladderScan®is noninvasive and comfortable for the patient. It is accurate, reliable, quick
and easy to use. When the user releases the scan button, within seconds, BladderScan®
measures ultrasonic reections on multiple planes inside the body and produces a three-
dimensional image. Based on this image, the BladderScan®BVI 9400 calculates and
displays the bladder volume. A sonographer is not required.
Patented NeuralHarmonics™ technology (abbreviated from “neural network harmonics”) in the
BVI 9400, sharpens accuracy and accelerates speed of measurement. Volume measurements
made with NeuralHarmonics™ technology are more accurate than those from conventional
two-dimensional ultrasound, as they are based on a more complex, multifaceted image of the
bladder. This technology, applying multi-spectral analysis to a robust data set, helps reduce
margin of error and minimize uncertainty in essential measurements of bladder function.
BladderScan®BVI 9400 measurements can be printed via an onboard printer or transmitted
using HIPAA-compliant ScanPoint®technology for storage and archiving on Verathon®servers.
Stored exams can be accessed at any time from your ofce’s computer for viewing or printing.
(NOTE: Use of ScanPoint®software is optional).
If needed, after a scan has been taken, a unique aiming icon guides the operator to optimal
probe placement with a comprehensive, three-dimensional display showing the bladder in
two cross-sectional images verifying that a complete scan has been achieved. Bladder
volume, patient type, directional aiming with real-time feedback, battery status, and usage
rate indicators are all displayed on the device’s LCD screen. The BladderScan®BVI 9400
contains an on-board thermal printer that allows the user to print exam results quickly with
the press of a button.
A Calibration Targeting System, consisting of a spiral-shaped calibration target along with
a purpose designed calibration container, allows the user to easily calibrate the device by
scanning a known target.
Optionally, exam results may be transmitted to a personal computer running ScanPoint®with
QuickPrint software via a proprietary wireless connection. ScanPoint®with QuickPrint allows the
user to archive data, calibrate the device, update software, print, and transfer data through
a Web-based interface.
The BladderScan®BVI 9400 system also includes a universal battery charger for the custom,
user-replaceable Lithium Ion battery incorporated in the system.
BladderScan®BVI 9400 Introducing the BladderScan®BVI 9400

User’s Manual page 18
The BladderScan®BVI 9400 may be mounted on a purpose-designed cart which holds
the instrument securely and provides a holder for ultrasound gel and other accessories.
The BladderScan®BVI 9400 is designed for simple, intuitive operation. However, to
ensure safe and effective operation, before using the device:
Familiarize yourself with the contents of this manual.•
Watch the training video provided on the instrument.•
BladderScan®Parts and Features
The BladderScan®BVI 9400 has two main components: the Console and the Probe.
The Console and Probe are linked by a detachable cable. The BladderScan®BVI 9400
controls and indicators are illustrated in Figure 1.
BladderScan®BVI 9400 Introducing the BladderScan®BVI 9400
Figure 1. BladderScan®BVI 9400 Controls and Indicators

User’s Manual page 19
Probe Components
The Probe transmits and receives ultrasound waves, automatically moving its internal
transducer 360º to scan twelve different planes to produce a three-dimensional image of the
bladder. The Probe is attached to the Console by a cable. The Probe has three main features:
Part Name Purpose
SCAN button Press to take a scan.
Aiming Display The LCD displays directional arrows to assure that the bladder is
centered within the scanning cone.
Microphone Records voice annotations.
Console Components
The Console provides all operating controls for the scanning process by means of ve
variable function buttons. The measured bladder volume and target-shaped aiming icons
are clearly displayed on the LCD screen. The Console also provides controls for adjusting
brightness and volume, turning the power on/off, interfacing with a ScanPoint®host computer
(optional), and adjusting user settings and preferences. The Console also houses the Battery
and the Printer. The Console’s controls and features are described in the following table:
Part Name Purpose
Main Display Displays the bladder volume measurement, patient type, settings,
and instrument status.
Power on/off Toggles main power on/off.
Volume Press to adjust volume up/down on voice annotation playback, start
up sound, and “scan complete” tone.
Brightness Press to adjust display brightness dimmer/brighter.
5 Variable Function Depending on device mode, the buttons provide access to all
Buttons instrument functions for scanning, recording annotations,
printing, connecting to ScanPoint®(optional), accessing the
training video, and setting user preferences.
Printer / Printer Door Press to release the Printer door.
BladderScan®BVI 9400 Introducing the BladderScan®BVI 9400

User’s Manual page 20
BladderScan®BVI 9400 Introducing the BladderScan®BVI 9400
Battery Charger/Wireless Hub
The BladderScan®BVI 9400 is powered by a Lithium Ion (Li-Ion) battery pack. The
battery charger provided with your BVI 9400 can charge two Li-Ion battery packs while
simultaneously functioning as the wireless hub linking your BVI 9400 to the ScanPoint®host
computer.
NOTE: Use of ScanPoint®with QuickPrint software is optional.
To provide power to the battery packs, the Battery Charger/Wireless Hub must be•
plugged into a wall outlet using the power cord provided.
To provide wireless communication between the BVI 9400 and the ScanPoint• ®
host computer, plug the Battery Charger/Wireless Hub USB connector into a USB
port on the ScanPoint®host computer.
The Battery Charger/Wireless Hub maintains an operating distance of up to 120 feet (36
meters) between the ScanPoint®computer and the BVI 9400, regardless of barriers such
as walls, ceilings, or windows.
Figure 2. Battery Charger & Wireless Hub